HPTN 083 explained
|
| HPTN 083 |
| Headerstyle: | background:#ccf; |
| Labelstyle: | background:#ddf; |
| Label2: | full name |
| Data2: | Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men |
| Label3: | other names |
| Data3: | CT02720094 |
| Label4: | sponsor |
| Data4: | ViiV Healthcare, Gilead Sciences[1] |
| Label5: | number of participants |
| Data5: | 4500 |
| Label6: | start |
| Data6: | 20 December 2016[2] |
| Label7: | end |
| Label8: | primary completion |
| Data8: | June 2020 |
HPTN 083 is a 2016 clinical trial which compares cabotegravir injections with oral use of Emtricitabine/tenofovir as pre-exposure prophylaxis ("PrEP") for prevention of HIV/AIDS.
The study seeks to test injectable PrEP as a way to remedy adherence for many patients on a daily pill regimen.[3]
HPTN 083 is the first large scale phase III clinical trial of cabotegravir.[4]
In February 2016 researchers presented the results of the ECLAIR study.[5] That study examined cabotegravir and found no serious safety concerns.[5]
The research is a collaboration of Gilead Sciences, HIV Prevention Trials Network, ViiV Healthcare, National Institute of Allergy and Infectious Diseases.[6]
Local study sites will include John H. Stroger Jr. Hospital of Cook County.[7]
On May 18, 2020, HPTN announced that the long-acting injections had been found to be a highly effective treatment.[8]
External links
Notes and References
- Web site: Safety and Efficacy Study of Injectable Cabotegravir Compared to Daily Oral Tenofovir Disoproxil Fumarate/Emtricitabine (TDF/FTC), For Pre-Exposure Prophylaxis in HIV-Uninfected Cisgender Men and Transgender Women Who Have Sex With Men. clinicaltrials.gov. 6 February 2017. en. 3 February 2017.
- Web site: NIH Launches First Large Trial of a Long-Acting Injectable Drug for HIV Prevention NIH: National Institute of Allergy and Infectious Diseases. www.niaid.nih.gov. 6 February 2017. en. 20 December 2016.
- News: Surugue. Léa. New PrEP drug could be a 'game-changer' to protect people from HIV infection. 6 February 2017. International Business Times UK. 28 December 2016.
- Web site: Rosa. Kristi. Will Cabotegravir be a Game-changer in HIV Prevention?. ContagionLive. 6 February 2017. 22 December 2016.
- Web site: Cairns. Gus. The 'long tail' problem: injected-PrEP trial will be extended due to persistence of drug in companion study. Aidsmap. 6 February 2017. 11 November 2016.
- Web site: 22 December 2016. Viiv HealthCare initiates Phase III HPTN 083 study of cabotegravir versus Truvadafor Pre-Exposure Prophylaxis (PrEP)to prevent HIV infection., 22-Dec-16. 6 February 2017. Medthority.com.
- Web site: Thomas. Monifa. CCHHS Part of First Study to Test Efficacy and Safety Of A New HIV-Prevention Medication. Daily Southtown. 6 February 2017. 9 January 2017.
- Web site: Long-acting injectable cabotegravir is highly effective for the prevention of HIV infection in cisgender men and transgender women who have sex with men The HIV Prevention Trials Network. www.hptn.org. 2020-05-18.
